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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stents, drains and dilators for the biliary ducts
510(k) Number K131201
Device Name ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET
Applicant
COOK, INC.
750 DANIELS WAY
Blmgtn,  IN  47404
Applicant Contact ERUM B NASIR
Correspondent
COOK, INC.
750 DANIELS WAY
Blmgtn,  IN  47404
Correspondent Contact ERUM B NASIR
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/29/2013
Decision Date 10/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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